ImmunoCard STAT! FLU A&B 782030

GUDID 00840733101656

ImmunoCard STAT! Flu A&B is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly form nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. Moderate Complexity when used with Nasal Wash/Aspirate Samples. CLIA Waived when used with Nasal and Nasopharyngeal Swabs.

MERIDIAN BIOSCIENCE, INC.

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Primary Device ID00840733101656
NIH Device Record Key5791d527-bfd9-4d0a-9f76-55d9812da2cd
Commercial Distribution StatusIn Commercial Distribution
Brand NameImmunoCard STAT! FLU A&B
Version Model Number782030
Catalog Number782030
Company DUNS092815364
Company NameMERIDIAN BIOSCIENCE, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(513) 271-3700
Emailinfo@meridianbioscience.com
Phone(513) 271-3700
Emailinfo@meridianbioscience.com
Phone(513) 271-3700
Emailinfo@meridianbioscience.com
Phone(513) 271-3700
Emailinfo@meridianbioscience.com
Phone(513) 271-3700
Emailinfo@meridianbioscience.com
Phone(513) 271-3700
Emailinfo@meridianbioscience.com
Phone(513) 271-3700
Emailinfo@meridianbioscience.com
Phone(513) 271-3700
Emailinfo@meridianbioscience.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100840733101656 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PSZDevices Detecting Influenza A, B, And C Virus Antigens

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-03-12

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